Recently, after his office reviewed thousands of medical records of seniors on Medicare, Dr. Levinson issued a disturbing report that found one in seven nursing home patients were given anti-psychotic drugs that may have increased their risk of sudden death.

The OIG report said 88 percent of the seniors who received the drugs had dementia. The Food and Drug Administration has stated very clearly that these drugs — called atypical anti-psychotics — should only be used to treat schizophrenia and bi-polar disorder, not dementia.

A few years ago, the FDA was so concerned about how atypical anti-psychotics were being prescribed that it issued a serious “black box” warning of an increased risk of death when the drugs are given to dementia patients. In spite of that warning, a number of reports documented the widespread prescribing of atypical anti-psychotics to seniors with both dementia and Alzheimer’s Disease.

When a drug is prescribed by a physician for a condition not approved by the FDA for that use it’s know as “off-label” prescribing. The practice is widespread — and is not illegal. But it has raised eyebrows in some quarters, and several drug companies have faced serious legal challenges for promoting their drugs for “off-label” use. That practice IS illegal.

Levinson’s report took on this issue, writing that “despite the fact that it is potentially lethal to prescribe anti-psychotics to patients with dementia, there’s ample evidence that some drug companies aggressively marketed their products towards such populations, putting profits before safety.”

Reaction to the report in the nursing home industry was not all negative. Dr. Kenneth Brubaker, a member of the board of the American Medical Directors Association acknowledged there is a problem with atypical anti-psychotic drugs in nursing homes. And, he said the report serves as a “wake-up call” for the nursing home industry to do a better job of training staff about their appropriate use.

Dr. Brubaker said the nursing home environment can be challenging when seniors are agitated and have disruptive behaviors. “When you’re in the trenches and you’ve tried everything else,” he said, sometimes it’s understandable when staff uses drugs to calm patients down. “You also have to think of the other patients,” he added.

On a personal note, I know how difficult a situation like that can be. My late mother, who had dementia, lived in a nursing home for most of the last year of her life. She often did not know where she was. She would tell me fantastic stories about how she was in jail and was being watched by the Secret Service because they thought she was dangerous. And while she was never disruptive, this was very upsetting to the whole family. But we did not allow her to be given anti-psychotic drugs.

Dr. Dilif Jeste, Director of the Sam and Rose Stein Institute for Research on Aging at the University of California, San Diego said “a part of the problem is that psychosis and agitation are very common in persons with dementia,” producing “considerable distress in the caregivers.” Dr. Jeste said dementia often hastens efforts on the part of family to have their loved ones admitted to a nursing home where many of the workers “are often low paid” and “not well trained to take care of elderly people with dementia.”

I can attest to that as well. Many of the staff at my Mom’s nursing home were low-wage employees, had almost no training in geriatrics and many of them received no employee health benefits. Presumably, not a bunch of happy campers.

I found I had to monitor everything related to her care because of this. I did that. But it was an incredibly difficult balancing act, especially with a job that requires extensive travel. I often wondered why the nursing home didn’t try some alternative approaches to dementia. But trying to change the culture of the entire place was way beyond my pay grade.

According to Dr. Jeste, “what is needed is a multi-pronged approach,” to dementia treatment, including cognitive stimulation therapy and music therapy. “Just as a child is not a small adult, an elderly person is not merely a chronically older person, therefore specialized training in the care of older people is vital.”

Kathy Cameron, a licensed pharmacist and consultant to The National Council on the Aging said she was “not surprised at the findings of the OIG.” She said although there is little documentation, she believes “there have been deaths” from atypical anti-psychotic drugs in nursing home patients. Cameron said the drugs increase the risk of heart failure and life threatening pneumonia when given to seniors with dementia.

She said families who have to institutionalize their relatives with dementia need to be “absolutely vigilant” about their loved one’s care including asking questions about new medications or changes in behavior.

More than 60 percent of all nursing homes patients living in nursing homes today have dementia or Alzheimer’s disease. And it’s projected that with the aging Baby Boomer generation the number of cases will double by 2030.

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